Safety and Efficacy Study of Isolagen TherapyTM in Treatment of Facial Wrinkles and Creases
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 10
- 主要终点
- Change in Subject Assessment of Wrinkles Compared to Baseline on Subject Wrinkle Assessment
研究概览
简要总结
The purpose of this study is to evaluate the safety profile and the treatment effect of autologous human fibroblasts and placebo when administered to facial wrinkles and creases
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, at least 18 years of age
- •High Investigator wrinkle severity assessment score
- •Subject assessment of dissatisfaction of facial appearance
- •Provide written informed consent and comply with the study requirements
- •Negative pregnancy test at screening visit
- •Healthy, non-scarred skin for biopsy
排除标准
- •Low Investigator wrinkle severity assessment score
- •Subject assessment of satisfaction of facial appearance
- •Physical attributes which prevent the assessment or treatment of the facial wrinkles
- •Treatment with an investigational product or procedure within 30 days or plans to participate in another clinical trial
- •Previous treatment with Isolagen Therapy
- •History of active autoimmune disease or organ transplantation
- •Diagnosis of cancer, receiving active treatment
- •History of pigmentary disorders which can affect the face
- •Active or chronic skin disease
- •Known genetic disorders affecting fibroblasts or collagen
- •Active systemic infection
- •Requires chronic antibiotic or steroidal therapy
- •Use of certain cosmetic treatments & procedures
- •Use of systemic agents that increase bleeding or clotting, or disorders equated with these effects
- •Pregnant or lactating women or women trying to become pregnant
- •Known allergic reaction to components of study treatment and/or study injection procedure
- •Excessive exposure to sun or sunburn in the post-auricular area
- •Subject has any disorder that may prevent compliance
- •Subject who is part of the study staff, a family member or friend
结局指标
主要结局
Change in Subject Assessment of Wrinkles Compared to Baseline on Subject Wrinkle Assessment
时间窗: Baseline (prior to first treatment) compared to 6 months post last treatment
Subject Wrinkle Assessment was a five point ordinal scale that assessed the subject's assessment of the appearance of their face. A score of -2 (very dissatisfied) was the worst and a score of +2 (very satisfied) was the best.
Independent Panel Global Improvement Assessment Compared to Baseline
时间窗: Baseline (prior to treatment) compared to 6 months post last treatment
An independent panel of physicians reviewed photographs of subjects at baseline and 6 months after final study treatment and provided a score for improvement in appearance on the Global Improvement Assessment. The Global Improvement Assessment was a four point ordinal scale with 0 (No improvement) as the worst score and 3 (Marked Improvement) the best.
次要结局
未报告次要终点